Parental Hesitancy and Attitude Concerning COVID-19 Vaccine and Its Side Effects in Saudi Arabia, Eastern Region

Background Vaccine hesitancy poses a substantial challenge to the field of public health. There are various factors that influence the willingness of parents to vaccinate their children. Addressing the factors contributing to vaccine hesitancy within the community has the potential to facilitate the development of more effective approaches for global vaccination initiatives. This study aims to assess parents' perspectives regarding the immunization of children aged five to 12 against COVID-19, including their experiences with adverse effects, as well as the factors that influence their hesitancy or acceptance of the vaccine in the Eastern Province of Saudi Arabia. Methods A web-based, cross-sectional study utilized an independently administered online questionnaire. The validated questionnaire was distributed to study participants through social networking platforms in order to recruit individuals from various locations in the eastern region of Saudi Arabia, such as Dammam, Al-Hassa, Al-Jubail, Ras Tanura, Dhahran, Al-Khobar, and Al-Qatif. Results The study encompassed a total of 399 participants. The most commonly reported adverse effects among the first and second children were pain at the injection site (1st child: 267 (66.70%), second child: 263 (66.20%)) and fever (1st child: 171 (43.10%), second child: 187 (47.50%)). A significant proportion of the participants, specifically 139 individuals (35%), expressed apprehension regarding immunization. This concern stemmed from various factors, including the fear of experiencing adverse effects, skepticism regarding the vaccine's efficacy, and exposure to potentially harmful information about the vaccine. Ninety-nine participants, accounting for 25% of the sample, indicated their agreement with the safety of COVID-19. Additionally, 104 participants, constituting 26% of the sample, held the belief that receiving vaccination aids in the prevention of severe illnesses caused by COVID-19. Notably, the most prevalent reason for vaccine hesitancy among participants was the fear of experiencing adverse effects. A total of 132 individuals, accounting for 33% of the participants, identified healthcare providers, including physicians and scientists, as reliable and trustworthy sources of vaccine information. A statistically significant correlation was observed between the demographic variables of the participants and their acceptance of the vaccine. Conclusion The study observed an acceptable vaccination rate among children aged five to 12 for the COVID-19 vaccine. Based on the investigation results, the primary apprehension expressed by parents regarding the immunization of their offspring pertained to the potential negative consequences associated with the vaccine. Nonetheless, it was observed that adverse effects were reported in less than fifty percent of vaccinated children. Addressing the concerns pertaining to the COVID-19 vaccination can enhance global participation in the immunization program aimed at mitigating future pandemics.


Introduction
The World Health Organization (WHO) labeled the coronavirus disease (COVID-19) outbreak a pandemic in March 2020.The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus now causes COVID-19, an infectious disease that affects people of all ages and causes respiratory illness [1].
Decades of research and evolutionary advances in immunology, vaccinology, and adjuvant biology have resulted in the quick development and clinical testing of viable vaccines to prevent the SARS-CoV-2 pandemic.The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommended BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine for persons 12 -15 years of age (this report refers to them as adolescents) on May 12, 2021, and for children aged five to 11 on the second of November 2021-2 [2][3][4].In clinical trials with children and adolescents, the vaccine's effectiveness was better than 90% [5].
As with other more common vaccines, side effects are inevitable and may be unpredicted [6].According to a survey carried out in the United States on the side effects of Pfizer-BioNTech COVID-19 vaccination that was given to children aged five to 11 years, 86.2% of all study participants experienced at least one local reaction at the site of injection, and 66.6% experienced at least one systemic reaction of mild to moderate severity [6].Fatigue, headaches, chills, and new or worsening muscle pain were the most prevalent complaints [6].The findings are consistent with the safety findings from the Pfizer-BioNTech COVID-19 vaccine prior approval trials, which were delivered to five to 11-year-old children [3].
Vaccinations for children under the age of 18 are frequently decided by their parents [7].According to the findings of a web-based survey developed by the study's researchers in partnership with vaccine specialists from the Department of Public Health in England, 48% of parents or guardians would favor COVID-19 vaccine for their children under the age of 18 [7].According to a Chinese study, parental approval of COVID-19 vaccination was much lower among physicians and nurses (44.5%) than among factory workers (72.6%) [8].One research conducted in Saudi Arabia on the adverse effects of the COVID-19 Pfizer-BioNTech vaccination in children aged 12 to 18 years found that the most prevalent side effect was soreness or redness at the injection site [9].
Another study that was carried out in Saudi Arabia to examine the prevalence and associated causes of vaccination hesitancy in children during the COVID-19 era found that most mothers firmly agreed with the need for vaccination, with the main reason being concerns about side effects [10].
Concerningly, parental vaccine reluctance in the Kingdom of Saudi Arabia is likely to impact their children's immunization status [11].In a research done in Saudi Arabia to pinpoint what influences parental acceptance and rejection, showed that immunization is the best strategy to prevent COVID-19 infection in themselves and their families and to stop the disease from spreading among the general population [12].Furthermore, parents disclosed that they refused to vaccinate both themselves and their children because of the efficiency (18.7%) and adverse effects (22.9%) of the COVID-19 vaccine [11,12].Additionally, some research shows a connection between participants' sociodemographic details and their perceptions of the effectiveness of the vaccine during the pandemic [11].A study done in various Eastern Mediterranean Region (EMR) countries to assess the link between parents' socio-demographic variables and the status of COVID-19 vaccination of their children revealed that parents' age, education level, occupation, prior COVID-19 infection, and vaccination status all had a significant influence on their children's immunization rates [13].Interestingly, parents who work or study in the health field are less likely to vaccinate their children than parents who work in other fields [13].
Most studies performed in Saudi Arabia focused on parents' willingness and intentions regarding getting their child immunized against COVID-19 to begin with [14].Our current study aims to investigate the COVID-19 vaccine's common side effects in children aged five to 12, assess parental attitudes, assess determinants of parental hesitancy, and determine the association between demographic characteristics and vaccination hesitancy in Saudi Arabia's eastern province.To the best of our knowledge, this study is the first in the literature to point out the determinants of parental hesitancy toward vaccination among those who have already received the vaccine in the region.

Study design
A cross-sectional study was performed on children between the ages of five and 12 utilizing a selfadministered online questionnaire for reporting adverse effects of the COVID-19 vaccine and parental acceptance towards immunization of children at this age against COVID-19.The study was conducted in Eastern province regions of Saudi Arabia including Dammam, Al-Hassa, Al-Jubail, Ras Tanura, Dhahran, Al-Khobar, and Al-Qatif during the period 2022 to 2023.

Study population and sample size
The study was successfully carried out in Saudi Arabia's Eastern Province, with a sample size of 384 participants.The sample size of parents of children between five to 12 years old is 384, which was obtained using the Richard Geiger equation, with a margin of error of 5%, a confidence of 95%, and a response distribution of 50% for the total children's population aged five to 12 (taken from the National Demographic Statistics Year 2016 participants) [15].The information was collected randomly using an electronic questionnaire.After giving informed consent, participants filled out the questionnaire on Google Forms to be involved in the study.

Selection criteria
The study encompassed parents residing in the Eastern province with children aged five to 12 years, regardless of their COVID-19 vaccination status.The study excluded parents residing outside of the Eastern province or whose children were less than five or older than 12 years of age.

Data collection
The primary method of data collection was survey-based and the sampling technique used was simple random.The survey was developed in Arabic using Google Forms, and the link was shared across social media platforms as well as through quick response (QR) code in various community gathering places in the Eastern Province regions of Saudi Arabia, such as shopping, and family parks from 2022 to 2023.The questionnaire was created following an extensive literature search that included PubMed, Medline, Google Scholar, and other databases [9,16], with the goal of identifying potential and frequent short-term adverse effects of the COVID-19 vaccine and discouraging parental approval or denial of children's COVID-19 vaccination.The first section contained an introduction to the study's objectives, contact information for the study authors to allow communication among research authors and participants, and a consent part where participants agreed to participate in the research.The second section gathered general data regarding the participants in the research (parents of children), such as gender, age, academic degree, marital status, and number of children.The third section gathered general data regarding the children, including sex, age, and long-term conditions, whether the child has been immunized against COVID-19 and the number of doses received, the adverse effects associated with the COVID-19 vaccination, and the timing the persistence of the adverse effects.The fourth and fifth sections were designed to collect information about the COVID-19 vaccine's adverse effects and parental attitudes toward COVID-19 and its vaccine (Appendix 1).

Validation and reliability testing of the questionnaire
A pilot investigation was carried out to determine the study's feasibility, reliability, and validity.The reliability of the constructs was tested using Cronbach's alpha, and all the alpha values were above 0.7.Validity was determined subjectively using face validity (expert opinions) and objectively by discriminate validity using the Fronell-Larcker criterion, and the square roots of average variance extracted (AVE) for each construct were found to be higher than the correlation between the same construct and the other constructs, which is a sign of discriminate validity (all values of AVE were more than 0.5).

Ethical issues
The confidentiality of the patient and the privacy of their data are priorities.Nothing that could raise ethical concerns, such as the participants' identities, was used.The ethical approval was granted by King Faisal University's College of Medicine's ethical committee (KFU-REC-2022-NOV-ETHICS301).

Statistical analysis
The data were analyzed using SPSS (BM Corp. Released 2019.IBM SPSS Statistics for Windows, Version 26.0.Armonk, NY: IBM Corp).The Chi-square test was used to test the association.Frequencies were used to present categorical variables while mean and standard deviation were used to represent continuous variables.A p-value of less than 0.05 for a 95% confidence interval was considered significant.

Results
Our study included 399 participants in total.The majority of the informants (82% were mothers), and around 39% of the participants ages ranged between 31 and 40 years.Regarding the education level of participants, more than half (57% had a bachelor's degree), 52% were employed, and 22% worked in the educational field.The vast majority of the participants (94% were married), and the rest were either divorced or widowed.More than half of the participants (51.6%) earned less than 15 thousand Saudi Arabian Riyals (SAR) as their monthly income.Regarding the number of children among the participants, less than one quarter, (22% had three children).Moreover, 16.3% of respondents reported their children had chronic diseases, distributed as asthma (6.5%), DM (6.3%), 5.3% sickle cell anemia (5.3%), other diseases (3%), and leukemia (2%).Overall, about half of the participants (48.9% of their five to 12-year-old children) had received the vaccine against COVID-19.Of those who had vaccinated their children, less than one quarter (22.6% of their first child) had received two doses, and 19.0% had received one dose of the vaccine against COVID-19 (Table 1).

Demographic Variables
Value  Regarding the side effects of the COVID-19 vaccine, less than half of respondents (48%) reported that their children had side effects.Also, more than one-third (35.1%) reported that the symptoms appeared after the first day of the vaccine, and one-quarter (25%) mentioned that the symptoms persisted for one to three days.

FIGURE 1: Side effects of COVID-19 vaccine
Regarding the attitude about COVID-19, 42% of respondents thought it was extremely likely that COVID-19 is a serious disease; 45% believed it was somewhat likely that they and their children are susceptible to COVID-19, and one quarter expressed their agreement with the safety of the COVID-19 vaccine.In addition, 26% strongly agreed that getting vaccinated helps prevent severe illnesses from COVID-19.Moreover, there were many concerns during the pandemic: 71% of the respondents feared that a family member would contract the virus, 57% worried that they would become infected, and 42% expressed concern over the possibility of death (

TABLE 3: Attitude towards COVID-19 and its vaccination (=399).
Regarding the acceptance and hesitancy of the COVID-19 vaccine, more than one-third of the participants (35%) were hesitant about the vaccination due to fearing side effects, thinking the vaccine might not be effective (15.8%), having read dangerous information about the vaccine (12%), or thinking the vaccine might interact with other diseases (11%).However, 40% of their children had received a vaccine against COVID-19 because it was mandatory, and 15% because they believed the vaccine would protect their children against COVID-19 (Table 4).

Causes of acceptance and refusal of vaccine against COVID-19
Value

TABLE 4: Causes of acceptance and hesitancy of COVID-19 vaccine (n=399).
Regarding the sources of information about the COVID-19 vaccine around one-third of participants (32.6%) mentioned healthcare providers (such as physicians and pharmacists, etc.) as a trusted source for information about vaccines, followed by the government (17.0%) and the internet (11.3%).Social media and pharmaceutical company reports were trusted by 8.5% and 3.3%, respectively, while 10.0% reported not trusting any source (Figure 2).

FIGURE 2: Sources of information regarding COVID-19 vaccine (n=399).
The demographic features of the participants (working field and income) had a statistically significant link with vaccine acceptability, according to the Chi-square test (p-value= 0.011).However, several other factors were not found to be associated.Furthermore according to the Chi-square statistic, fear of side effects, the belief that the vaccine might not be effective, and having read dangerous information about the vaccine were all significantly associated with hesitance to receive the COVID-19 vaccine at the 0.05 level.(Tables 5, 6).

Variables
Did all children (ages 5-12) receive the vaccine against COVID-  The vaccines may cause some health problems in the future 0.0% 0.0% Death of one of the family members 6.2% 6.4% I have read dangerous information about the vaccine 13.3% 11.3% There are not enough studies on the vaccine and its side effects 1.0% 0.5% The vaccine may interact with other diseases 12.8% 10.3%

TABLE 6: Association between concerns about getting COVID-19 vaccine and status of vaccination (n=399).
* The Chi-square statistic is significant at the 0.05 level

Discussion
This study aims to identify Saudi parents' hesitancy and behaviors regarding COVID-19 vaccinations of their children aged five to 12 years old and to investigate the causes of acceptance and hesitancy that may encourage or prevent Saudi parents from vaccinating their children against the COVID-19 virus.The COVID-19 immunization in Saudi Arabia was expanded to children over the age of 12 in June 2021 and to children aged five to 11 in January 2022 [17].
This study demonstrates the actual percentage of children who have been vaccinated, in contrast to prior studies, which have only shown parents' intentions to vaccinate their children.
The primary concerns of parents in the current study about vaccinating their children were the possible adverse effects of the vaccine (35%), thinking the vaccine might not be effective (15.8%), having read dangerous information about the vaccine (12%), or thinking the vaccine might interact with other diseases (11%).These findings are consistent with earlier research in Egypt, where the primary worries were the vaccine's adverse effects (68.3%) and ideas of conspiracies (18%) [24], and in Malaysia, where the common reasons against vaccination were uncertainty regarding the new vaccine (96.1%), concerns regarding vaccine ingredients (93.2%), shortage of vaccine information provided from clinicians (82.3%), and the notion that vaccines are unsafe (79.8%) [25].Several previous studies have found that parents are hesitant to vaccinate their children because of worries regarding adverse side effects: 42.9% in Saudi Arabia [14], 46.8% in Romania [28], 61.5% in Boston [29], 76.9% in Turkey [19] and 84.1% in Korea [16].
The current study revealed that the primary factors that prompted parents to give their children the COVID-19 vaccine were that it was mandatory (40%), and to protect their children against COVID-19 (15%).Moreover, working field and high income had a statistically significant correlation with vaccine acceptance.Previous studies in Malaysia showed that the reasons for willingly immunizing children were for their protection (99.4%), protection of their family members (99.3%), and effectiveness (98.2%) [26].Protecting the child's health was the main reason for parent's acceptance among previous studies in Saudi Arabia (24.1%) [14], UAE (55.5%) [27] and Turkey (75.5%) [19].
According to the current study, approximately one-third of the respondents (32.6%) cited healthcare providers as a reliable source of vaccine information, followed by the government (17.0%), the internet (11.3%), and social media (8.5%).These findings are consistent with previous studies in the United States, where 64.88% of respondents relied on healthcare providers for information about the vaccine, while 15% reported relying on social media [30].In contrast, a previous study in Palestine reported that social media, the internet, and healthcare professionals were the main sources of information about the COVID-19 vaccine (22.07%, 18.74%, and 11.92%, respectively) [31].These variations in information sources highlight the importance of understanding the local context when developing communication strategies and policies to encourage vaccine uptake.
The current study reports that 42% of respondents thought it was extremely likely that COVID-19 is a serious disease, 45% believed it was somewhat likely that they and their children are susceptible to COVID-19, and one quarter expressed their agreement with the safety of the COVID-19 vaccine.In addition, 26% strongly agreed that getting vaccinated helps prevent severe illnesses from COVID-19.Moreover, there were many concerns during the pandemic, where 71% of the respondents feared that a family member would contract the virus, 57% worried that they would become infected, and 42% expressed concern over the possibility of death.These findings are similar to findings in previous studies in Najran, Saudi Arabia, in which nearly 70% of parents agreed that the COVID-19 vaccine was effective [32] and in Italy, where 78.7% agreed that COVID-19 is a serious disease and 42.3% agreed that it is preventable [25].
Regarding the side effects of the COVID-19 vaccine, less than half of those who responded (48%) reported that their children had side effects.More than one-third (35.1%) reported that the symptoms appeared after the first day of the vaccine, and one-quarter (25%) mentioned that the symptoms persisted for one to three days.The most frequent adverse effects experienced by the first and second children were pain at the injection site (first child: 66.70%, second child: 66.20%), fever (first child: 43.10%, second child: 47.50%), swelling at the injection site (first child: 33.30%, second child: 38.10%), and headache (first child: 31.30%,second child: 28.10%).These findings are consistent with previous studies at the national level, which reported that 50.4% of children experienced side effects.The majority of them (78.9%) said that adverse effects began one day after receiving the immunization, and 65.7% reported that they lasted one to three days.In addition, the most documented effect was pain at the injection site (15.3%)[33].The World Health Organization (WHO) stated that COVID-19 vaccines, like other vaccines, could cause adverse effects.However, most of these adverse effects were minor and of short duration [34].

Limitations of the study
Our study demonstrated some limitations.One of them is that as there is no central immunization record in Saudi Arabia for the COVID-19 vaccine and the parents reported the child's vaccination status, this could potentially be underestimated or overstated due to social desirability or recollection bias.In addition, instead of a direct face-to-face interview, study results were recorded via a web-based, self-administered survey.This may result in prejudice in reporting their responses.

Question Options
Are the side effects that appeared on your children similar to each other?

No
What are the effects of the effects that your first child suffered after taking the vaccine?(you can choose more than one answer): with raised red and white spots above the surface of the skin Infections in the corners of the lips Mouth ulcers Numbness of the mouth A change in the sense of taste dry mouth Change in mouth odor Bleeding gums Swellings in the sides of the inner mouth What are the effects of the effects that your first child suffered after taking the vaccine?(you can choose more than one answer): al. Cureus 15(11): e48776.DOI 10.7759/cureus.48776financial support was received from any organization for the submitted work.Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work.Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.